1. Field of the Invention
The present invention generally relates to methods and systems for the screening and detection of disease and more particularly to methods and systems for the screening and detection of persons at risk for developing type II diabetes mellitus.
2. Background of the Invention
Type II diabetes mellitus is a life changing disease that affects millions of persons. While the disease may be clinically diagnosed and confirmed fairly easily in some cases, earlier detection may lead to the possibility of intervention(s) that would alter or lessen the onset of clinical symptoms or allow other forms of preventative care to be undertaken.
Currently, one of the best approaches for predicting who may be at risk for developing type II diabetes mellitus before onset of clinical symptoms is by the oral glucose tolerance test (OGTT). The OGTT, is inconvenient, requires fasting and is not highly reproducible. The fasting blood glucose (FBG) is less burdensome, but much less sensitive, particularly in older Americans who have the highest prevalence of diabetes and pre-diabetes. The quantitation of Hemoglobin A1c (a glycated form of hemoglobin) from blood has been widely used as a test for assessing the adequacy of glycemic control and risk of complications in diabetic patients, but this test is not sufficiently sensitive to detect the range of glucose values typically seen in pre-diabetes or new onset type II diabetes. Furthermore, there are many variants of hemoglobin present in blood. This is particularly applicable in minority populations disproportionately affected by diabetes, and this adds additional uncertainty to the use of this test. A simplified, less burdensome approach to the diagnosis of diabetes and pre-diabetes would facilitate increased recognition and improved care of these individuals. While progress has been made to improve the accuracy and reproducibility of the measurement of surrogate biomarkers predictive of those at high risk for developing type II diabetes, a set of candidate biomarkers would benefit the clinical community, particularly if such surrogate biomarkers result in higher sensitivity and specificity.
Accordingly, what is needed is a method and system of screening for persons with increased risk of developing type II diabetes mellitus that utilizes candidate biomarkers allowing for broad based, reliable screening of large population bases. In addition, effective strategies for characterizing, archiving, and contrasting data from multiple sample types under varying conditions (e.g. control versus disease) are also needed.
Additional advantages and novel features of the present invention will be set forth as follows and will be readily apparent from the descriptions and demonstrations set forth herein. Accordingly, the following descriptions of the present invention should be seen as illustrative of the invention and not as limiting in any way.